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• Strategy

  Build road maps for the nonclinical development of new drug products

  • Enable first-in-man clinical studies through marketing authorization
    • Optimize opportunities for streamlined programs and study waivers
    • Coordinate multi-year scientific programs to support go/ no-go business decisions
  • Characterize small molecules and biologics
    • Niche expertise in dermatologic, ophthalmic, and hematologic indications
  • Develop realistic timelines and budgets
• Empirical Study

  Design scientific assessments to meet regulatory objectives

  • Enable INDs and NDAs/BLAs with toxicology studies conducted in accordance with FDA and ICH Guidances, Good Laboratory Practices, and industry standards
  • Address clinical hold concerns
  • Meet post-marketing committments

  Manage wet-lab experiments at external toxicology laboratories

  • Guide CROs through critical, time-sensitive decision-making to achieve regulatory goals
  • Coordinate a cohesive program, interpreting all findings against the same standards and principles to discern the data throughline
  • Structure multi-year scientific programs to support clinical timelines
• Submissions & Representation

  Contextualize scientific findings in integrated toxicology assessments for Regulatory submissions to the US FDA, Health Canada, and the EMA

  • Compose nonclinical sections of IND/CTA/IMPDs, NDA/NDS/MAAs, IBs, CAC communications, safety informational amendments, waiver requests, meeting requests, briefing books, and package inserts
  • Define margins of safety to enable risk/benefit analysis

  Position Nonclinical in meetings with Regulatory Agencies

  • Achieve pre-IND/CTA, EOP2, pre-NDA/NDS, and Type A and C Guidance meeting goals
• Due Diligence

  Conduct nonclinical due diligence for product acquisitions

  • Identify program gaps
  • Project budgets and timelines for advancement

Contact Tox Clarity to Get Started

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